Prenatal Screening for Congenital Heart Diseases in the Antwerp Region
NCT ID: NCT04382222
Last Updated: 2020-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2500 participants
OBSERVATIONAL
2020-06-01
2021-12-31
Brief Summary
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Detailed Description
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However, identifying fetal cardiac abnormalities early in pregnancy is essential. Early diagnosis allows extensive cardiac ultrasound, genetic testing and planning delivery in a paediatric-cardiac centre offering optimal neonatal care.
It also may allow the future parents to consider and decide for a termination of pregnancy in case of a severe fetal heart malformation with poor prognosis.
The investigator conducts a retrospective study on 2500 cases of congenital heart diseases over 20 years. Detailed data for this were made available by the EUROCAT Antwerp registry, a population-based database with controlled, reliable and robust data.
The study wants to reveal the prevalence and prenatal diagnostic sensitivity of congenital heart defects in the EUROCAT regions Antwerp (Flanders) and especially the evolution of the prenatal diagnostic rate over time.
In the second phase, a similar study in two adjacent regions, Hainaut (Wallonia, Belgium) and Groningen (The Netherlands) will follow.
On condition of correct statistic processing, these data will be suitable to compare the prevalence and to benchmark diagnostic rates of congenital heart defects in these three regions.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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prenatal ultrasound
prenatal cardiac ultrasound
Eligibility Criteria
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Inclusion Criteria
* In the period 1/1/1997-31/12/2017 period
Exclusion Criteria
* All cases of congenital heart diseases were the parents did not allow inclusion in the EUROCAT registered.
* All cases of congenital heart diseases where the mother delivered outside the EC countries.
18 Years
49 Years
FEMALE
No
Sponsors
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Universiteit Antwerpen
OTHER
Responsible Party
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Prof Yves Jacquemyn
Professor
Principal Investigators
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Paul Ramaekers, MD
Role: STUDY_CHAIR
University Antwerpen
Yves Jacquemyn
Role: STUDY_CHAIR
University Antwerpen
Locations
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University Hospital Antwerp
Edegem, Antwerp, Belgium
Countries
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Central Contacts
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Yves Jacquemyn, PhD
Role: CONTACT
Other Identifiers
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20/16/205 - 001126
Identifier Type: -
Identifier Source: org_study_id
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